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Human Medicines Withdrawn ProductsThis list was last updated on
Sunday, November 22, 2020
Please NoteThe contents of the table are believed to be correct
at the time of compilation. The HPRA makes no representations or
warranties about and disclaim all liability for the content,
accuracy, completeness or suitability of the information contained
in the table for any purpose whatsoever and the information is made
available to the public for information purposes only.
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateCreon 40000 Gastro-resistant
Capsules
Mylan IRE Healthcare Limited
PA2010/008/003 400 milligram(s) Gastro-resistant capsule -
Pancreas powder 16/11/2020
Creon 40000 Gastro-resistant Capsules
Mylan IRE Healthcare Limited
PA2010/008/003 400 milligram(s) Gastro-resistant capsule -
Pancreas powder 16/11/2020
Xatral 2.5mg Film-Coated Tablets
LTT Pharma Limited PPA1562/020/002 2.5 milligram(s) Film-coated
tablet - ALFUZOSIN HYDROCHLORIDE
06/11/2020
Xatral 2.5mg Film-Coated Tablets
LTT Pharma Limited PPA1562/020/002 2.5 milligram(s) Film-coated
tablet - ALFUZOSIN HYDROCHLORIDE
06/11/2020
NovoMix 30 NovoLet Novo Nordisk A/S EU/1/00/142/006 100
unit(s)/millilitre Suspension for injection - Insulin aspart
04/11/2020
NOVOMIX 70 FlexPen Novo Nordisk A/S EU/1/00/142/0020-23 100 U/ml
unit(s)/millilitre Suspension for injection - Insulin aspart
04/11/2020
NOVOMIX 70 FlexPen Novo Nordisk A/S EU/1/00/142/0020-23 100 U/ml
unit(s)/millilitre Suspension for injection - Insulin aspart
04/11/2020
NovoSeven Novo Nordisk A/S EU/1/96/006/001 0.6 micromole(s)
Powder and solvent for solution for injection
- Factor viia human, recombinant
04/11/2020
NovoSeven Novo Nordisk A/S EU/1/96/006/002 2.4 milligram(s)
Powder and solvent for solution for injection
- Factor viia human, recombinant
04/11/2020
Primolut N 5 mg Tablets Bayer Limited PA1410/010/001 5
milligram(s) Tablet - Norethisterone 04/11/2020
Primolut N 5 mg Tablets Bayer Limited PA1410/010/001 5
milligram(s) Tablet - Norethisterone 04/11/2020
BRAVELLE 75 IU powder and solvent for solution for injection
Ferring Ireland Ltd PA1009/019/001 75 international unit(s)
Powder and solvent for solution for injection
- Urofollitropin 03/11/2020
BRAVELLE 75 IU powder and solvent for solution for injection
Ferring Ireland Ltd PA1009/019/001 75 international unit(s)
Powder and solvent for solution for injection
- Urofollitropin 03/11/2020
Flursil Relief Sugar Free 8.75 mg lozenges
Rowex Ltd PA0711/257/001 8.75 milligram(s) Lozenge -
Flurbiprofen 03/11/2020
Flursil Relief Sugar Free 8.75 mg lozenges
Rowex Ltd PA0711/257/001 8.75 milligram(s) Lozenge -
Flurbiprofen 03/11/2020
Tadalafil Rowex 10 mg Film-coated Tablets
Rowex Ltd PA0711/261/003 10 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Tadalafil Rowex 10 mg Film-coated Tablets
Rowex Ltd PA0711/261/003 10 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Tadalafil Rowex 2.5 mg Film-coated Tablets
Rowex Ltd PA0711/261/001 2.5 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Tadalafil Rowex 2.5 mg Film-coated Tablets
Rowex Ltd PA0711/261/001 2.5 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Tadalafil Rowex 5 mg Film-coated Tablets
Rowex Ltd PA0711/261/002 5 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Tadalafil Rowex 5 mg Film-coated Tablets
Rowex Ltd PA0711/261/002 5 milligram(s) Film-coated tablet -
Tadalafil 03/11/2020
Fucidin 250mg/5ml Oral Suspension
Leo Laboratories Limited PA0046/004/010 250 mg/5ml Oral
suspension - Fusidic acid anhydrous 31/10/2020
Fucidin 250mg/5ml Oral Suspension
Leo Laboratories Limited PA0046/004/010 250 mg/5ml Oral
suspension - Fusidic acid anhydrous 31/10/2020
Ivabradine 5 mg Film-coated Tablets
Accord Healthcare Ireland Ltd.
PA2315/224/001 5 milligram(s) Film-coated tablet - Ivabradine
30/10/2020
Ivabradine 5 mg Film-coated Tablets
Accord Healthcare Ireland Ltd.
PA2315/224/001 5 milligram(s) Film-coated tablet - Ivabradine
30/10/2020
Ivabradine 7.5 mg Film-coated Tablets
Accord Healthcare Ireland Ltd.
PA2315/224/002 7.5 milligram(s) Film-coated tablet - Ivabradine
30/10/2020
Ivabradine 7.5 mg Film-coated Tablets
Accord Healthcare Ireland Ltd.
PA2315/224/002 7.5 milligram(s) Film-coated tablet - Ivabradine
30/10/2020
TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w,
Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
Human Medicines Withdrawn Products Page 1 of 704
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Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateTCP First Aid Antiseptic
Cream.TCP Liquid Antiseptic 25% w/w, Chloroxylenol 0.5% w/w,
Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w,
Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w,
Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w,
Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w,
Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w
Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent
weight/weight
Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan
30/10/2020
TCP Liquid AntisepticHalogenated Phenols 0.68% w/vPhenol 0.175%
w/v
Chefaro Ireland DAC PA1186/005/002 0.68%w/v+0.175 percent
weight/volume
Cutaneous solution - Halogenated phenols- Phenol
30/10/2020
TCP Liquid AntisepticHalogenated Phenols 0.68% w/vPhenol 0.175%
w/v
Chefaro Ireland DAC PA1186/005/002 0.68%w/v+0.175 percent
weight/volume
Cutaneous solution - Halogenated phenols- Phenol
30/10/2020
Ciproxin Bayer Limited PA1410/028/001 100 milligram(s) Tablet -
CIPROFLOXACIN HYDROCHLORIDE
29/10/2020
Ciproxin Bayer Limited PA1410/028/001 100 milligram(s) Tablet -
CIPROFLOXACIN HYDROCHLORIDE
29/10/2020
Ciproxin Bayer Limited PA1410/028/005 2 milligram(s)/millilitre
Solution for infusion - Ciprofloxacin lactate 29/10/2020Ciproxin
Bayer Limited PA1410/028/005 2 milligram(s)/millilitre Solution for
infusion - Ciprofloxacin lactate 29/10/2020Ciproxin IV Flexibag
Bayer Limited PA1410/028/010 2 milligram(s)/millilitre Solution for
infusion - Ciprofloxacin lactate 29/10/2020Ciproxin IV Flexibag
Bayer Limited PA1410/028/010 2 milligram(s)/millilitre Solution for
infusion - Ciprofloxacin lactate 29/10/2020Ciproxin Oral Suspension
250mg/5ml
Bayer Limited PA1410/028/008 5.0 gram(s) - Ciprofloxacin
29/10/2020
Ciproxin Oral Suspension 250mg/5ml
Bayer Limited PA1410/028/008 5.0 gram(s) - Ciprofloxacin
29/10/2020
Ciproxin Oral Suspension Forte 500 mg/5ml
Bayer Limited PA1410/028/009 10.0 gram(s) - Ciprofloxacin
29/10/2020
Ciproxin Oral Suspension Forte 500 mg/5ml
Bayer Limited PA1410/028/009 10.0 gram(s) - Ciprofloxacin
29/10/2020
Alverine citrate 120mg capsules, hard
Incepta Euro Limited PA22965/001/002 120 milligram(s) Capsule,
hard - ALVERINE CITRATE 21/10/2020
Alverine citrate 120mg capsules, hard
Incepta Euro Limited PA22965/001/002 120 milligram(s) Capsule,
hard - ALVERINE CITRATE 21/10/2020
Alverine citrate 60mg capsules, hard
Incepta Euro Limited PA22965/001/001 60 milligram(s) Capsule,
hard - ALVERINE CITRATE 21/10/2020
Alverine citrate 60mg capsules, hard
Incepta Euro Limited PA22965/001/001 60 milligram(s) Capsule,
hard - ALVERINE CITRATE 21/10/2020
Kolbam Retrophin Europe Limited
EU/1/13/895/001 50 milligram(s) Capsule, hard - Cholic acid
21/10/2020
Kolbam Retrophin Europe Limited
EU/1/13/895/001 50 milligram(s) Capsule, hard - Cholic acid
21/10/2020
Kolbam Retrophin Europe Limited
EU/1/13/895/002 250 milligram(s) Capsule, hard - Cholic acid
21/10/2020
Kolbam Retrophin Europe Limited
EU/1/13/895/002 250 milligram(s) Capsule, hard - Cholic acid
21/10/2020
Dostinex 500 microgram Tablets
Lexon (UK) Ltd PPA1097/029/001 0.5 milligram(s) Tablet -
Cabergoline 16/10/2020
Dostinex 500 microgram Tablets
Lexon (UK) Ltd PPA1097/029/001 0.5 milligram(s) Tablet -
Cabergoline 16/10/2020
Human Medicines Withdrawn Products Page 2 of 704
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Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateStelazine 1mg/5ml Syru Amdipharm
Limited PA1142/037/003 1 mg/5ml Syrup - Trifluoperazine
16/10/2020
Stelazine 1mg/5ml Syru Amdipharm Limited PA1142/037/003 1 mg/5ml
Syrup - Trifluoperazine 16/10/2020
Ponalgic 250mg Hard Capsules
Mercury Pharmaceuticals (Ireland) Ltd
PA0073/097/001 250 milligram(s) Capsule - Mefenamic acid
15/10/2020
Ponalgic 250mg Hard Capsules
Mercury Pharmaceuticals (Ireland) Ltd
PA0073/097/001 250 milligram(s) Capsule - Mefenamic acid
15/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/027 . percent volume/volume Solution for injection -
Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/028 . percent volume/volume Solution for injection -
Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/039 60,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/040 60,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/001 500 international unit(s) Powder and solvent for
solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/001 500 international unit(s) Powder and solvent for
solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/002 500 international unit(s) Powder and solvent for
solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/003 500 international unit(s) Powder and solvent for
solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/004 1000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/005 1000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/007 2000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/008 2000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/010 5000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/011 5000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/012 10,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/013 10,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon for Reco-Pen
Roche Registration Limited
EU/1/97/031/021 10,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon for Reco-Pen
Roche Registration Limited
EU/1/97/031/022 10,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon for Reco-Pen
Roche Registration Limited
EU/1/97/031/024 20,000 international unit(s)
- Epoetin beta 12/10/2020
NeoRecormon Multidose Roche Registration Limited
EU/1/97/031/020 100,000 international unit(s)
Powder and solvent for solution for injection
- Epoetin beta 12/10/2020
NeoRecormon Recopen Roche Registration Limited
EU/1/97/031/023 20,000 international unit(s)
Powder for solution for injection
- Epoetin beta 12/10/2020
Oxaliplatin Hospira 5 mg/ml Concentrate for Solution for
Infusion
Hospira UK Limited PA0437/056/002 5 milligram(s)/millilitre
Concentrate for solution for infusion
- Oxaliplatin 12/10/2020
Oxaliplatin Hospira 5 mg/ml Concentrate for Solution for
Infusion
Hospira UK Limited PA0437/056/002 5 milligram(s)/millilitre
Concentrate for solution for infusion
- Oxaliplatin 12/10/2020
Phenobarbital 60 mg Tablets
Clonmel Healthcare Ltd PA0126/019/003 60 milligram(s) Tablet -
PHENOBARBITAL 12/10/2020
Phenobarbital 60 mg Tablets
Clonmel Healthcare Ltd PA0126/019/003 60 milligram(s) Tablet -
PHENOBARBITAL 12/10/2020
Zyban 150 mg prolonged release tablets
PCO Manufacturing Ltd. PPA0465/089/002 150 milligram(s)
Prolonged-release tablet - Bupropion hydrochloride
12/10/2020
Zyban 150 mg prolonged release tablets
PCO Manufacturing Ltd. PPA0465/089/002 150 milligram(s)
Prolonged-release tablet - Bupropion hydrochloride
12/10/2020
Kaletra AbbVie Deutschland GmbH & Co. KG
EU/1/01/172/001 133,3/33,3 milligram(s) Capsule - Lopinavir-
Ritonavir
06/10/2020
Kaletra AbbVie Deutschland GmbH & Co. KG
EU/1/01/172/001 133,3/33,3 milligram(s) Capsule - Lopinavir-
Ritonavir
06/10/2020
Human Medicines Withdrawn Products Page 3 of 704
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Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateINACTIVATED INFLUENZA VACCINE
(SPLIT VIRION) BP, suspension for injection in prefilled
syringe.Influenza vaccine (split virion, inactivated)
Sanofi Pasteur PA2131/012/001 15/15/15mc percent
volume/volume
Suspension for injection - A/Michigan/45/2015 (H1N1)pdm09 - like
strain (A/Michigan/45/2015, NYMC X-275)- A/hong kong/4801/2014
(h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)-
B/brisbane/60/2008 - like strain (b/brisbane/60/2008)
05/10/2020
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for
injection in prefilled syringe.Influenza vaccine (split virion,
inactivated)
Sanofi Pasteur PA2131/012/001 15/15/15mc percent
volume/volume
Suspension for injection - A/Michigan/45/2015 (H1N1)pdm09 - like
strain (A/Michigan/45/2015, NYMC X-275)- A/hong kong/4801/2014
(h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)-
B/brisbane/60/2008 - like strain (b/brisbane/60/2008)
05/10/2020
Invirase Roche Registration GmbH
EU/1/96/026/001 200 milligram(s) Capsule - Saquinavir
05/10/2020
Invirase Roche Registration GmbH
EU/1/96/026/001 200 milligram(s) Capsule - Saquinavir
05/10/2020
Mircera Roche Registration Limited
EU/1/07/400/001 50/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/002 100/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/002 100/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/003 200/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/003 200/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/004 300/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/004 300/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/005 400/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/005 400/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/006 600/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/006 600/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/007 1000/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/007 1000/1 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/14 400/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/14 400/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/15 600/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/15 600/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/16 800/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH
EU/1/07/400/16 800/0.6 microgram(s)/millilitre
Solution for injection - Ro0503821 05/10/2020
NeoRecormon Roche Registration Limited
EU/1/97/031/009 2000 international unit(s) Powder and solvent
for solution for injection
- Epoetin beta 05/10/2020
Tamiflu Roche Registration GmbH
EU/1/02/222/002 12 micromole(s) Powder for oral suspension
- Oseltamivir phosphate 05/10/2020
Human Medicines Withdrawn Products Page 4 of 704
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Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateMethotrexate 10 mg tablets
Orion Corporation PA1327/009/002
Interchangeable List Code:IC0098-002-002
10 milligram(s) Tablet - Methotrexate 02/10/2020
Methotrexate 10 mg tablets
Orion Corporation PA1327/009/002
Interchangeable List Code:IC0098-002-002
10 milligram(s) Tablet - Methotrexate 02/10/2020
Methotrexate 2.5mg Tablets
Orion Corporation PA1327/009/001
Interchangeable List Code:IC0098-018-002
2.5 milligram(s) Tablet - Methotrexate 02/10/2020
Methotrexate 2.5mg Tablets
Orion Corporation PA1327/009/001
Interchangeable List Code:IC0098-018-002
2.5 milligram(s) Tablet - Methotrexate 02/10/2020
Paracetamol 500 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/030/001 500 milligram(s) Film-coated tablet - PARACETAMOL
01/10/2020
Paracetamol 500 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/030/001 500 milligram(s) Film-coated tablet - PARACETAMOL
01/10/2020
Truoxin 250 mg Film-coated Tablets
Fannin Limited PA1457/013/001 250 milligram(s) Film-coated
tablet - Ciprofloxacin 30/09/2020
Truoxin 250 mg Film-coated Tablets
Fannin Limited PA1457/013/001 250 milligram(s) Film-coated
tablet - Ciprofloxacin 30/09/2020
Truoxin 500 mg Film-coated Tablets
Fannin Limited PA1457/013/002 500 milligram(s) Film-coated
tablet - Ciprofloxacin 30/09/2020
Truoxin 500 mg Film-coated Tablets
Fannin Limited PA1457/013/002 500 milligram(s) Film-coated
tablet - Ciprofloxacin 30/09/2020
Kaletra AbbVie Ltd EU/1/01/172/002 percent volume/volume Capsule
- Ritonavir- Lopinavir
28/09/2020
Kaletra AbbVie Ltd EU/1/01/172/002 percent volume/volume Capsule
- Ritonavir- Lopinavir
28/09/2020
Norvir AbbVie Ltd EU/1/96/016/001 80 milligram(s)/millilitre
Infus/Pdr/Oral Soln - Ritonavir 28/09/2020Norvir AbbVie Ltd
EU/1/96/016/001 80 milligram(s)/millilitre Infus/Pdr/Oral Soln -
Ritonavir 28/09/2020Norvir Soft Capsules AbbVie Ltd EU/1/96/016/003
100 milligram(s) Capsule - Ritonavir 28/09/2020Norvir Soft Capsules
AbbVie Ltd EU/1/96/016/003 100 milligram(s) Capsule - Ritonavir
28/09/2020Nicochew Fruit 2 mg medicated chewing-gum
Clonmel Healthcare Ltd PA0126/263/001 2 milligram(s) Medicated
chewing-gum - Nicotine 24/09/2020
Nicochew Fruit 2 mg medicated chewing-gum
Clonmel Healthcare Ltd PA0126/263/001 2 milligram(s) Medicated
chewing-gum - Nicotine 24/09/2020
Nicochew Fruit 4 mg medicated chewing-gum
Clonmel Healthcare Ltd PA0126/263/002 4 milligram(s) Medicated
chewing-gum - Nicotine 24/09/2020
Nicochew Fruit 4 mg medicated chewing-gum
Clonmel Healthcare Ltd PA0126/263/002 4 milligram(s) Medicated
chewing-gum - Nicotine 24/09/2020
Vepacel Ology Bioservices Ireland LTD
EU/1/12/752/001 7.5 microgram(s)
Suspension for injection - Whole virion non-adjuvanted influenza
virus (a/vietnam/1203/2004 (h5n1))
24/09/2020
Vepacel Ology Bioservices Ireland LTD
EU/1/12/752/001 7.5 microgram(s)
Suspension for injection - Whole virion non-adjuvanted influenza
virus (a/vietnam/1203/2004 (h5n1))
24/09/2020
TechneScan LyoMAA, Powder for suspension for injection/kit for
radiopharmaceutical preparation
Mallinckrodt Medical B.V.
PA0690/012/001 2.0 milligram(s) Powder for suspension for
injection
- Human albumin macro aggregated
21/09/2020
TechneScan LyoMAA, Powder for suspension for injection/kit for
radiopharmaceutical preparation
Mallinckrodt Medical B.V.
PA0690/012/001 2.0 milligram(s) Powder for suspension for
injection
- Human albumin macro aggregated
21/09/2020
Prapexin 0.26 mg prolonged release tablets
Rowex Ltd PA0711/242/001 0.26 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Human Medicines Withdrawn Products Page 5 of 704
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Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DatePrapexin 0.26 mg prolonged
release tablets
Rowex Ltd PA0711/242/001 0.26 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 0.52 mg prolonged release tablets
Rowex Ltd PA0711/242/002 0.52 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 0.52 mg prolonged release tablets
Rowex Ltd PA0711/242/002 0.52 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 1.05 mg prolonged release tablets
Rowex Ltd PA0711/242/003 1.05 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 1.05 mg prolonged release tablets
Rowex Ltd PA0711/242/003 1.05 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 2.1 mg prolonged release tablets
Rowex Ltd PA0711/242/004 2.1 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 2.1 mg prolonged release tablets
Rowex Ltd PA0711/242/004 2.1 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 3.15 mg prolonged release tablets
Rowex Ltd PA0711/242/005 3.15 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Prapexin 3.15 mg prolonged release tablets
Rowex Ltd PA0711/242/005 3.15 milligram(s) Prolonged-release
tablet - Pramipexole 17/09/2020
Quedute 0.5 mg soft capsules
Rowex Ltd PA0711/276/001 0.5 milligram(s) Capsule, soft -
Dutasteride 16/09/2020
Quedute 0.5 mg soft capsules
Rowex Ltd PA0711/276/001 0.5 milligram(s) Capsule, soft -
Dutasteride 16/09/2020
Mannitol Intravenous Infusion BP 20% w/v Solution for
Infusion
Baxter Healthcare Limited
PA0167/037/009 20 percent weight/volume
Solution for infusion - Mannitol 13/09/2020
Mannitol Intravenous Infusion BP 20% w/v Solution for
Infusion
Baxter Healthcare Limited
PA0167/037/009 20 percent weight/volume
Solution for infusion - Mannitol 13/09/2020
Sodium Chloride (Normal Saline) 0.9% w/v Eye Drops Solution
Martindale Pharmaceuticals Ltd
PA0361/012/001 0.9 percent weight/volume
Eye drops, solution - Sodium chloride 11/09/2020
Glycerol 2g Suppositories
Ethypharm PA0549/028/002 2 gram(s) Suppository - Glycerol
10/09/2020
Glycerol 2g Suppositories
Ethypharm PA0549/028/002 2 gram(s) Suppository - Glycerol
10/09/2020
Hyoscine Injection BP 400 micrograms/ml, Solution for
Injection
Ethypharm PA0549/031/001 400 microgram(s)/millilitre
Solution for injection - Hyoscine Hydrobromide
10/09/2020
Treosulfan Powder for Solution for Injection or Infusion 5 g
medac Gesellschaft für klinische Spezialpräparate mbH
PA0623/001/002 5 gram(s) Powder for solution for
injection/infusion
- Treosulfan 10/09/2020
Treosulfan Powder for Solution for Injection or Infusion 5 g
medac Gesellschaft für klinische Spezialpräparate mbH
PA0623/001/002 5 gram(s) Powder for solution for
injection/infusion
- Treosulfan 10/09/2020
Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/284/001 600/300 milligram(s)
Film-coated tablet - Abacavir- Lamivudine
09/09/2020
Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/284/001 600/300 milligram(s)
Film-coated tablet - Abacavir- Lamivudine
09/09/2020
CosmoFer 50mg/ml solution for infusion and injection
Lexon (UK) Ltd PPA1097/034/001 50 milligram(s)/millilitre
Solution for injection/infusion
- Iron 09/09/2020
Selectol Tablets 200 mg Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/126/001 200 milligram(s) Tablet - CELIPROLOL
HYDROCHLORIDE
08/09/2020
Selectol Tablets 200 mg Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/126/001 200 milligram(s) Tablet - CELIPROLOL
HYDROCHLORIDE
08/09/2020
Selectol Tablets 400mg Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/126/002 400
milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE
08/09/2020
Selectol Tablets 400mg Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/126/002 400
milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE
08/09/2020
Advantan 0.1% w/w Fatty Ointment
LEO Pharma A/S PA1025/013/003 0.1
percent weight/weight
Ointment - Methylprednisolone aceponate
04/09/2020
Advantan 0.1% w/w Ointment
LEO Pharma A/S PA1025/013/002 0.1
percent weight/weight
Ointment - Methylprednisolone aceponate
04/09/2020
Advantan cream 0.1% w/w
LEO Pharma A/S PA1025/013/001 0.1
percent weight/weight
Cream - Methylprednisolone aceponate
04/09/2020
Human Medicines Withdrawn Products Page 6 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateDalacin T Topical 10 mg/ml
Cutaneous Solution
Pfizer Healthcare Ireland PA0822/121/002 10
milligram(s)/millilitre Cutaneous solution - CLINDAMYCIN
PHOSPHATE
03/09/2020
Dalacin T Topical 10 mg/ml Cutaneous Solution
Pfizer Healthcare Ireland PA0822/121/002 10
milligram(s)/millilitre Cutaneous solution - CLINDAMYCIN
PHOSPHATE
03/09/2020
Telfast 180mg film-coated tablets
Lexon (UK) Ltd PPA1097/057/001 180 milligram(s) Film-coated
tablet - Fexofenadine hydrochloride
03/09/2020
Telfast 180mg film-coated tablets
Lexon (UK) Ltd PPA1097/057/001 180 milligram(s) Film-coated
tablet - Fexofenadine hydrochloride
03/09/2020
Asasantin Retard 200mg/25mg Modified Release Hard Capsules
Imbat Limited PPA1151/128/001 200/25 milligram(s) Capsules
Modified Release
- Aspirin- Dipyridamole
01/09/2020
Asasantin Retard 200mg/25mg Modified Release Hard Capsules
Imbat Limited PPA1151/128/001 200/25 milligram(s) Capsules
Modified Release
- Aspirin- Dipyridamole
01/09/2020
Atacand 16mg tablets Imbat Limited PPA1151/109/001
Interchangeable List Code:IC0009-038-002
16 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Atacand 16mg tablets Imbat Limited PPA1151/109/001
Interchangeable List Code:IC0009-038-002
16 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Atacand 4 mg tablets Imbat Limited PPA1151/109/002
Interchangeable List Code:IC0009-008-002
4 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Atacand 4 mg tablets Imbat Limited PPA1151/109/002
Interchangeable List Code:IC0009-008-002
4 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Atacand 8 mg tablets Imbat Limited PPA1151/109/003
Interchangeable List Code:IC0009-009-002
8 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Atacand 8 mg tablets Imbat Limited PPA1151/109/003
Interchangeable List Code:IC0009-009-002
8 milligram(s) Tablet - Candesartan cilexetil 01/09/2020
Becotide Evohaler 50 micrograms, Pressurised Inhalation
Solution
Imbat Limited PPA1151/204/002 50 microgram(s) Pressurised
inhalation, solution
- Beclometasone dipropionate
01/09/2020
Becotide Evohaler 50 micrograms, Pressurised Inhalation
Solution
Imbat Limited PPA1151/204/002 50 microgram(s) Pressurised
inhalation, solution
- Beclometasone dipropionate
01/09/2020
Benylin Day & Night Tablets
Imbat Limited PPA1151/264/001 500/60 & 25 milligram(s)
Tablet - Diphenhydramine hydrochloride- PSEUDOEPHEDRINE
HYDROCHLORIDE- Paracetamol
01/09/2020
Benylin Day & Night Tablets
Imbat Limited PPA1151/264/001 500/60 & 25 milligram(s)
Tablet - Diphenhydramine hydrochloride- PSEUDOEPHEDRINE
HYDROCHLORIDE- Paracetamol
01/09/2020
Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg
Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride
22.5mg
Imbat Limited PPA1151/130/001 500 12.5 22.5 milligram(s)
Film-coated tablet - Diphenhydramine- Pseudoephedrine-
Paracetamol
01/09/2020
Human Medicines Withdrawn Products Page 7 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateBenylin Four Flu Film-Coated
Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg
Pseudoephedrine hydrochloride 22.5mg
Imbat Limited PPA1151/130/001 500 12.5 22.5 milligram(s)
Film-coated tablet - Diphenhydramine- Pseudoephedrine-
Paracetamol
01/09/2020
Coversyl Arginine Plus 10mg/2.5mg film-coated tablets
LTT Pharma Limited PPA1562/063/002 10/2.5 milligram(s)
Film-coated tablet - Indapamide- Perindopril arginine
28/08/2020
Coversyl Arginine Plus 10mg/2.5mg film-coated tablets
LTT Pharma Limited PPA1562/063/002 10/2.5 milligram(s)
Film-coated tablet - Indapamide- Perindopril arginine
28/08/2020
Provigil 200 mg Tablets Lexon (UK) Ltd PPA1097/024/001 200
milligram(s) Tablet - Modafinil 28/08/2020Provigil 200 mg Tablets
Lexon (UK) Ltd PPA1097/024/001 200 milligram(s) Tablet - Modafinil
28/08/2020Ibuprofen/Phenylephrine Clonmel 400 mg/10 mg film-coated
tablets
Clonmel Healthcare Ltd PA0126/296/001 400/10 milligram(s)
Film-coated tablet - Ibuprofen- Phenylephrine hydrochloride
27/08/2020
Arcoxia 30 mg film-coated tablets
Imbat Limited PPA1151/137/001
Interchangeable List Code:IC0108-033-003
30 milligram(s) Film-coated tablet - Etoricoxib 25/08/2020
Arcoxia 30 mg film-coated tablets
Imbat Limited PPA1151/137/001
Interchangeable List Code:IC0108-033-003
30 milligram(s) Film-coated tablet - Etoricoxib 25/08/2020
Aromasin 25 mg coated tablets
Imbat Limited PPA1151/178/001 25 milligram(s) Coated tablet -
Exemestane 25/08/2020
Aromasin 25 mg coated tablets
Imbat Limited PPA1151/178/001 25 milligram(s) Coated tablet -
Exemestane 25/08/2020
Arthrotec 50 modified-release tablets
Imbat Limited PPA1151/199/001
Interchangeable List Code:IC0058-109-021
50/0.2 milligram(s) Modified-release tablet - DICLOFENAC SODIUM-
Misoprostol
25/08/2020
Arthrotec 50 modified-release tablets
Imbat Limited PPA1151/199/001
Interchangeable List Code:IC0058-109-021
50/0.2 milligram(s) Modified-release tablet - DICLOFENAC SODIUM-
Misoprostol
25/08/2020
Arthrotec 75 modified-release tablets
Imbat Limited PPA1151/199/002
Interchangeable List Code:IC0058-113-021
75/0.2 milligram(s) Modified-release tablet - Misoprostol-
DICLOFENAC SODIUM
25/08/2020
Arthrotec 75 modified-release tablets
Imbat Limited PPA1151/199/002
Interchangeable List Code:IC0058-113-021
75/0.2 milligram(s) Modified-release tablet - Misoprostol-
DICLOFENAC SODIUM
25/08/2020
Asacolon 400 mg Gastro-resistant Tablets
Imbat Limited PPA1151/107/001 400 milligram(s) Gastro-resistant
tablet - Mesalazine 25/08/2020
Asacolon 400 mg Gastro-resistant Tablets
Imbat Limited PPA1151/107/001 400 milligram(s) Gastro-resistant
tablet - Mesalazine 25/08/2020
Asacolon 800mg Gastro-resistant Tablets
Imbat Limited PPA1151/107/003 800 milligram(s) Gastro-resistant
tablet - Mesalazine 25/08/2020
Asacolon 800mg Gastro-resistant Tablets
Imbat Limited PPA1151/107/003 800 milligram(s) Gastro-resistant
tablet - Mesalazine 25/08/2020
By-Vertin 8 mg Tablets Fannin Limited PA1457/011/001
Interchangeable List Code:IC0084-009-002
8 milligram(s) Tablet - Betahistine dihydrochloride
25/08/2020
By-Vertin 8 mg Tablets Fannin Limited PA1457/011/001
Interchangeable List Code:IC0084-009-002
8 milligram(s) Tablet - Betahistine dihydrochloride
25/08/2020
Eslicarbazepine acetate Mylan 800 mg Tablets
McDermott Laboratories Ltd., T/A Gerard Laboratories
PA0577/231/001 800 milligram(s) Tablet - Eslicarbazepine
acetate
25/08/2020
Human Medicines Withdrawn Products Page 8 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateEslicarbazepine acetate Mylan 800
mg Tablets
McDermott Laboratories Ltd., T/A Gerard Laboratories
PA0577/231/001 800 milligram(s) Tablet - Eslicarbazepine
acetate
25/08/2020
Amaryl 2mg Tablets Imbat Limited PPA1151/063/002 2 milligram(s)
Tablet - Glimepiride 24/08/2020Amaryl 2mg Tablets Imbat Limited
PPA1151/063/002 2 milligram(s) Tablet - Glimepiride
24/08/2020Amaryl 4mg Tablets Imbat Limited PPA1151/063/003 4
milligram(s) Tablet - Glimepiride 24/08/2020Amaryl 4mg Tablets
Imbat Limited PPA1151/063/003 4 milligram(s) Tablet - Glimepiride
24/08/2020Arcoxia 120 mg film-coated tablets
Imbat Limited PPA1151/137/004
Interchangeable List Code:IC0108-167-003
120 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arcoxia 120 mg film-coated tablets
Imbat Limited PPA1151/137/004
Interchangeable List Code:IC0108-167-003
120 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arcoxia 60 mg film-coated tablets
Imbat Limited PPA1151/137/002
Interchangeable List Code:IC0108-127-003
60 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arcoxia 60 mg film-coated tablets
Imbat Limited PPA1151/137/002
Interchangeable List Code:IC0108-127-003
60 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arcoxia 90 mg film-coated tablets
Imbat Limited PPA1151/137/003
Interchangeable List Code:IC0108-166-003
90 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arcoxia 90 mg film-coated tablets
Imbat Limited PPA1151/137/003
Interchangeable List Code:IC0108-166-003
90 milligram(s) Film-coated tablet - Etoricoxib 24/08/2020
Arimidex 1 mg film-coated tablets
Imbat Limited PPA1151/161/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 24/08/2020
Arimidex 1 mg film-coated tablets
Imbat Limited PPA1151/161/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 24/08/2020
Omeprazole Teva Pharma 10 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/001
Interchangeable List Code:IC0010-002-016
10 milligram(s) Gastro-resistant capsule - Omeprazole
20/08/2020
Omeprazole Teva Pharma 10 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/001
Interchangeable List Code:IC0010-002-016
10 milligram(s) Gastro-resistant capsule - Omeprazole
20/08/2020
Omeprazole Teva Pharma 20 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/002
Interchangeable List Code:IC0010-003-016
20 milligram(s) Gastro-resistant capsule - Omeprazole
20/08/2020
Omeprazole Teva Pharma 20 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/002
Interchangeable List Code:IC0010-003-016
20 milligram(s) Gastro-resistant capsule - Omeprazole
20/08/2020
Omeprazole Teva Pharma 40 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/003
Interchangeable List Code:IC0010-004-016
40 milligram(s) Gastro-resistant capsule, hard
- Omeprazole 20/08/2020
Omeprazole Teva Pharma 40 mg Gastro-resistant capsules, hard
Teva Pharma B.V. PA0749/092/003
Interchangeable List Code:IC0010-004-016
40 milligram(s) Gastro-resistant capsule, hard
- Omeprazole 20/08/2020
Human Medicines Withdrawn Products Page 9 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateActifed 60mg/2.5mg tablets
Imbat Limited PPA1151/210/001 60/2.5 milligram(s) Tablet -
TRIPROLIDINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE
19/08/2020
Actifed 60mg/2.5mg tablets
Imbat Limited PPA1151/210/001 60/2.5 milligram(s) Tablet -
TRIPROLIDINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE
19/08/2020
Acular 0.5% w/v eye drops, solution
Imbat Limited PPA1151/142/001 0.5 percent weight/volume
Eye drops, solution - Ketorolac trometamol 19/08/2020
Acular 0.5% w/v eye drops, solution
Imbat Limited PPA1151/142/001 0.5 percent weight/volume
Eye drops, solution - Ketorolac trometamol 19/08/2020
Adalat LA 30mg Prolonged-Release Tablet
Imbat Limited PPA1151/047/002 30 milligram(s) Prolonged-release
tablet - Nifedipine 19/08/2020
Adalat LA 30mg Prolonged-Release Tablet
Imbat Limited PPA1151/047/002 30 milligram(s) Prolonged-release
tablet - Nifedipine 19/08/2020
Adalat Retard 20 mg Prolonged-Release Tablets
Imbat Limited PPA1151/047/001 20 milligram(s) Prolonged-release
tablet - Nifedipine 19/08/2020
Adalat Retard 20 mg Prolonged-Release Tablets
Imbat Limited PPA1151/047/001 20 milligram(s) Prolonged-release
tablet - Nifedipine 19/08/2020
Aldactone 25mg Film-coated Tablets
Imbat Limited PPA1151/197/001 25 milligram(s) Film-coated tablet
- Spironolactone 19/08/2020
Aldactone 25mg Film-coated Tablets
Imbat Limited PPA1151/197/001 25 milligram(s) Film-coated tablet
- Spironolactone 19/08/2020
Amaryl 1mg Tablets Imbat Limited PPA1151/063/001 1 milligram(s)
Tablet - Glimepiride 19/08/2020Amaryl 1mg Tablets Imbat Limited
PPA1151/063/001 1 milligram(s) Tablet - Glimepiride
19/08/2020Dilzem XL 120mg Prolonged-release hard capsules
Teva B.V. PA1986/089/004 120 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Dilzem XL 120mg Prolonged-release hard capsules
Teva B.V. PA1986/089/004 120 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Dilzem XL 180mg Prolonged-release Hard Capsules
Teva B.V. PA1986/089/005 180 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Dilzem XL 180mg Prolonged-release Hard Capsules
Teva B.V. PA1986/089/005 180 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Dilzem XL 240mg Prolonged-release Hard Capsules
Teva B.V. PA1986/089/006 240 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Dilzem XL 240mg Prolonged-release Hard Capsules
Teva B.V. PA1986/089/006 240 milligram(s) Prolonged-release
capsule
- Diltiazem hydrochloride 17/08/2020
Glucobay 100 mg Tablets
Bayer Limited PA1410/029/002 100 milligram(s) Tablet - Acarbose
17/08/2020
Glucobay 100 mg Tablets
Bayer Limited PA1410/029/002 100 milligram(s) Tablet - Acarbose
17/08/2020
Glucobay 50 mg Tablets Bayer Limited PA1410/029/001 50
milligram(s) Tablet - Acarbose 17/08/2020
Glucobay 50 mg Tablets Bayer Limited PA1410/029/001 50
milligram(s) Tablet - Acarbose 17/08/2020
By-Vertin 16 mg Tablets Fannin Limited PA1457/011/002
Interchangeable List Code:IC0084-038-002
16 milligram(s) Tablet - Betahistine dihydrochloride
15/08/2020
By-Vertin 16 mg Tablets Fannin Limited PA1457/011/002
Interchangeable List Code:IC0084-038-002
16 milligram(s) Tablet - Betahistine dihydrochloride
15/08/2020
Qtrilmet AstraZeneca AB EU/1/19/1401/001-014 850/2.5/5
milligram(s) Modified-release tablet - Saxagliptin- METFORMIN
HYDROCHLORIDE- Dapagliflozin
14/08/2020
Tadalafil Clonmel 10 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/003 10 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 10 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/003 10 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Human Medicines Withdrawn Products Page 10 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateTadalafil Clonmel 2.5 mg
Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/001 2.5 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 2.5 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/001 2.5 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 20 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/004 20 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 20 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/004 20 milligram(s)
Film-coated tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 5 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/002 5 milligram(s) Film-coated
tablet - Tadalafil 14/08/2020
Tadalafil Clonmel 5 mg Film-coated Tablets
Clonmel Healthcare Ltd PA0126/283/002 5 milligram(s) Film-coated
tablet - Tadalafil 14/08/2020
Grisol 1% w/w Cutaneous Spray solution
Transdermal Limited PA0991/001/001 1 percent weight/weight
Cutaneous spray, solution
- Griseofulvin 12/08/2020
MONTELUKAST Paediatric 4mg Chewable Tablets
Aurobindo Pharma (Malta) Limited
PA1445/015/002
Interchangeable List Code:IC0023-008-007
4 milligram(s) Chewable tablet - Montelukast sodium
11/08/2020
MONTELUKAST Paediatric 4mg Chewable Tablets
Aurobindo Pharma (Malta) Limited
PA1445/015/002
Interchangeable List Code:IC0023-008-007
4 milligram(s) Chewable tablet - Montelukast sodium
11/08/2020
Zileze 7.5 mg Film-Coated Tablets
Chiesi Limited PA0743/007/003
Interchangeable List Code:IC0055-041-003
7.5 milligram(s) Film-coated tablet - Zopiclone 11/08/2020
Zileze 7.5 mg Film-Coated Tablets
Chiesi Limited PA0743/007/003
Interchangeable List Code:IC0055-041-003
7.5 milligram(s) Film-coated tablet - Zopiclone 11/08/2020
Lidotec 700 mg medicated plaster
Grunenthal Pharma Ltd PA2242/009/001 5 percent Medicated plaster
- Lidocaine 10/08/2020
Lidotec 700 mg medicated plaster
Grunenthal Pharma Ltd PA2242/009/001 5 percent Medicated plaster
- Lidocaine 10/08/2020
Salmeterol Neolab 25 micrograms per metered dose pressurised
inhalation suspension
Fannin Limited PA1457/024/001 25 microgram(s) Pressurised
inhalation, suspension
- Salmeterol 07/08/2020
Salmeterol Neolab 25 micrograms per metered dose pressurised
inhalation suspension
Fannin Limited PA1457/024/001 25 microgram(s) Pressurised
inhalation, suspension
- Salmeterol 07/08/2020
Suprecur 150 micrograms/ metered dose Nasal Spray, solution
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/073/002 150 microgram(s) Nasal spray, solution -
Buserelin 02/08/2020
Suprecur 150 micrograms/ metered dose Nasal Spray, solution
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/073/002 150 microgram(s) Nasal spray, solution -
Buserelin 02/08/2020
Suprefact 1 mg/ml Solution for Injection
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/074/001 1 milligram(s)/millilitre Solution for injection
- Buserelin 02/08/2020
Suprefact 1 mg/ml Solution for Injection
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/074/001 1 milligram(s)/millilitre Solution for injection
- Buserelin 02/08/2020
Duzallo Grünenthal GmbH EU/1/18/1300/001-002 200/200
milligram(s) Film-coated tablet - Lesinurad- Allopurinol
31/07/2020
Duzallo Grünenthal GmbH EU/1/18/1300/003-004 300/200
milligram(s) Film-coated tablet - Allopurinol- Lesinurad
31/07/2020
Pilocarpine 2% w/v Eye Drops, Solution
Martindale Pharmaceuticals Ltd
PA0361/010/001 2 percent weight/volume Eye drops, solution -
Pilocarpine hydrochloride
31/07/2020
Pilocarpine 2% w/v Eye Drops, Solution
Martindale Pharmaceuticals Ltd
PA0361/010/001 2 percent weight/volume Eye drops, solution -
Pilocarpine hydrochloride
31/07/2020
Rythmodan Retard 250 mg Prolonged-release Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/069/004 250 milligram(s) Prolonged-release tablet -
Disopyramide 31/07/2020
Rythmodan Retard 250 mg Prolonged-release Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/069/004 250 milligram(s) Prolonged-release tablet -
Disopyramide 31/07/2020
Human Medicines Withdrawn Products Page 11 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateTarivid IV 2 mg/ml Solution for
Infusion
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/076/002 2 milligram(s)/millilitre Solution for infusion -
Ofloxacin 31/07/2020
Tarivid IV 2 mg/ml Solution for Infusion
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/076/002 2 milligram(s)/millilitre Solution for infusion -
Ofloxacin 31/07/2020
Aripiprazole Accord Healthcare 10 mg tablet
Accord Healthcare Ireland Ltd.
PA2315/026/002
Interchangeable List Code:IC0092-002-056
10 milligram(s) Tablet - Aripiprazole 30/07/2020
Aripiprazole Accord Healthcare 10 mg tablet
Accord Healthcare Ireland Ltd.
PA2315/026/002
Interchangeable List Code:IC0092-002-056
10 milligram(s) Tablet - Aripiprazole 30/07/2020
Zemplar 5 micrograms/ml Solution for Injection, glass vial
AbbVie Limited PA1824/005/005 5 microgram(s)/millilitre Solution
for injection - Paricalcitol 29/07/2020
Zemplar 5 micrograms/ml Solution for Injection, glass vial
AbbVie Limited PA1824/005/005 5 microgram(s)/millilitre Solution
for injection - Paricalcitol 29/07/2020
Cardioplegia Concentrate for Solution for Infusion
(163mg/60mg/14mg per ml)
Martindale Pharmaceuticals Ltd
PA0361/014/001 163mg/ml + 60mg/ml+14 milligram(s)/millilitre
Concentrate for solution for infusion
- Potassium chloride- Procaine hydrochloride- Magnesium
chloride
27/07/2020
Chloramphenicol 0.5% w/v Eye Drops
Martindale Pharmaceuticals Ltd
PA0361/013/001 0.5 percent weight/volume
Eye drops, solution - Chloramphenicol 27/07/2020
Chloramphenicol 0.5% w/v Eye Drops
Martindale Pharmaceuticals Ltd
PA0361/013/001 0.5 percent weight/volume
Eye drops, solution - Chloramphenicol 27/07/2020
Chloramphenicol 1% w/w Eye Ointment
Ethypharm PA0549/025/002 1 percent weight/weight Eye ointment -
Chloramphenicol 27/07/2020
Chloramphenicol 1% w/w Eye Ointment
Ethypharm PA0549/025/002 1 percent weight/weight Eye ointment -
Chloramphenicol 27/07/2020
Clarithromycin Martindale Pharma 500 mg Powder for Concentrate
for Solution for Infusion
Martindale Pharmaceuticals Ltd
PA0361/025/001 500 milligram(s) Pdr/Conc/Soln for Infus -
Clarithromycin 27/07/2020
Clarithromycin Martindale Pharma 500 mg Powder for Concentrate
for Solution for Infusion
Martindale Pharmaceuticals Ltd
PA0361/025/001 500 milligram(s) Pdr/Conc/Soln for Infus -
Clarithromycin 27/07/2020
Cyclizine Lactate 50 mg/ml Solution for Injection
Ethypharm PA0549/033/001 50 milligram(s)/millilitre Solution for
injection - Cyclizine 27/07/2020
Cyclizine Lactate 50 mg/ml Solution for Injection
Ethypharm PA0549/033/001 50 milligram(s)/millilitre Solution for
injection - Cyclizine 27/07/2020
Granisetron Martindale Pharma 1mg/1ml Concentrate for Solution
for Injection/Infusion
Martindale Pharmaceuticals Ltd
PA0361/029/001 1 milligram(s)/millilitre Concentrate for
solution for injection
- Granisetron hydrochloride
27/07/2020
Granisetron Martindale Pharma 3mg/3ml Concentrate for Solution
for Injection/Infusion
Martindale Pharmaceuticals Ltd
PA0361/029/002 3mg/3ml Concentrate for solution for
injection
- Granisetron hydrochloride
27/07/2020
Granisetron Martindale Pharma 3mg/3ml Concentrate for Solution
for Injection/Infusion
Martindale Pharmaceuticals Ltd
PA0361/029/002 3mg/3ml Concentrate for solution for
injection
- Granisetron hydrochloride
27/07/2020
Midazolam 5 mg/ml Solution for injection or infusion
Martindale Pharmaceuticals Ltd
PA0361/021/001 5 milligram(s)/millilitre Solution for
injection/infusion
- MIDAZOLAM HYDROCHLORIDE
27/07/2020
Midazolam 5 mg/ml Solution for injection or infusion
Martindale Pharmaceuticals Ltd
PA0361/021/001 5 milligram(s)/millilitre Solution for
injection/infusion
- MIDAZOLAM HYDROCHLORIDE
27/07/2020
Pethidine Injection BP 100mg/2ml
Martindale Pharmaceuticals Ltd
PA0361/008/003 100/2 milligram(s)/millilitre
Solution for injection - PETHIDINE HYDROCHLORIDE
27/07/2020
Pethidine Injection BP 100mg/2ml
Martindale Pharmaceuticals Ltd
PA0361/008/003 100/2 milligram(s)/millilitre
Solution for injection - PETHIDINE HYDROCHLORIDE
27/07/2020
Pethidine Injection BP 50mg/ml
Martindale Pharmaceuticals Ltd
PA0361/008/002 50 milligram(s)/millilitre Solution for injection
- PETHIDINE HYDROCHLORIDE
27/07/2020
Human Medicines Withdrawn Products Page 12 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DatePethidine Injection BP
50mg/ml
Martindale Pharmaceuticals Ltd
PA0361/008/002 50 milligram(s)/millilitre Solution for injection
- PETHIDINE HYDROCHLORIDE
27/07/2020
Pethidine Tablets BP 50 mg
Martindale Pharmaceuticals Ltd
PA0361/008/001 50 milligram(s) Tablet - PETHIDINE
HYDROCHLORIDE
27/07/2020
Pethidine Tablets BP 50 mg
Martindale Pharmaceuticals Ltd
PA0361/008/001 50 milligram(s) Tablet - PETHIDINE
HYDROCHLORIDE
27/07/2020
Phenobarbital Sodium 15mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/001 15 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Phenobarbital Sodium 15mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/001 15 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Phenobarbital Sodium 30mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/002 30 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Phenobarbital Sodium 30mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/002 30 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Phenobarbital Sodium 60mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/003 60 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Phenobarbital Sodium 60mg/ml Solution for Injection
Martindale Pharmaceuticals Ltd
PA0361/005/003 60 milligram(s)/millilitre Solution for injection
- Phenobarbital sodium 27/07/2020
Drytec 2.5-100 GBq radionuclide generator
GE Healthcare B.V. PA22734/002/001 2.5-100 gigabecquerel(s
Radionuclide generator - Sodium Molybdate.99 Mo
24/07/2020
Flexove 625 mg tablets Laboratoires Expanscience
PA1616/001/001 625 milligram(s) Tablet - Glucosamine
22/07/2020
Flexove 625 mg tablets Laboratoires Expanscience
PA1616/001/001 625 milligram(s) Tablet - Glucosamine
22/07/2020
Ariclaim Eli Lilly Nederland B.V. EU/1/04/283/1-6 40
milligram(s) Gastro-resistant capsule - Duloxetine
hydrochloride
16/07/2020
Ariclaim Eli Lilly Nederland B.V. EU/1/04/283/1-6 40
milligram(s) Gastro-resistant capsule - Duloxetine
hydrochloride
16/07/2020
Zurampic Grünenthal GmbH EU/1/15/1080/001-005 200 milligram(s)
Film-coated tablet - Lesinurad 16/07/2020Gastrolief 20 mg
gastro-resistant tablets
Clonmel Healthcare Ltd PA0126/220/001 20 milligram(s)
Gastro-resistant tablet - Pantoprazole 15/07/2020
Gastrolief 20 mg gastro-resistant tablets
Clonmel Healthcare Ltd PA0126/220/001 20 milligram(s)
Gastro-resistant tablet - Pantoprazole 15/07/2020
Anafranil 10mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/002 10 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Anafranil 10mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/002 10 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Anafranil 25mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/003 25 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Anafranil 25mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/003 25 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Anafranil 50mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/001 50 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Anafranil 50mg Capsules
Novartis Pharmaceuticals UK Ltd
PA0013/084/001 50 milligram(s) Capsule - Clomipramine
hydrochloride
10/07/2020
Captor 25 mg Tablets Rowex Ltd PA0711/002/002 25 milligram(s)
Tablet - Captopril 10/07/2020Captor 25 mg Tablets Rowex Ltd
PA0711/002/002 25 milligram(s) Tablet - Captopril 10/07/2020Ranitic
150 mg Film-coated tablets
Rowex Ltd PA0711/024/001
Interchangeable List Code:IC0087-062-051
150 milligram(s) Film-coated tablet - RANITIDINE
HYDROCHLORIDE
07/07/2020
Ranitic 150 mg Film-coated tablets
Rowex Ltd PA0711/024/001
Interchangeable List Code:IC0087-062-051
150 milligram(s) Film-coated tablet - RANITIDINE
HYDROCHLORIDE
07/07/2020
Ranitic 300 mg Film-coated tablets
Rowex Ltd PA0711/024/002
Interchangeable List Code:IC0087-029-051
300 milligram(s) Film-coated tablet - RANITIDINE
HYDROCHLORIDE
07/07/2020
Human Medicines Withdrawn Products Page 13 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateRanitic 300 mg Film-coated
tablets
Rowex Ltd PA0711/024/002
Interchangeable List Code:IC0087-029-051
300 milligram(s) Film-coated tablet - RANITIDINE
HYDROCHLORIDE
07/07/2020
Ranitic 75 mg Film-coated tablets
Rowex Ltd PA0711/024/004 75 milligram(s) Film-coated tablet -
RANITIDINE HYDROCHLORIDE
07/07/2020
Ranitic 75 mg Film-coated tablets
Rowex Ltd PA0711/024/004 75 milligram(s) Film-coated tablet -
RANITIDINE HYDROCHLORIDE
07/07/2020
Paramax 500mg/5mg Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/154/001 500mg/5 milligram(s) Tablet - Paracetamol-
Metoclopramide hydrochloride
02/07/2020
Paramax 500mg/5mg Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/154/001 500mg/5 milligram(s) Tablet - Paracetamol-
Metoclopramide hydrochloride
02/07/2020
Captor 12.5mg Tablets Rowex Ltd PA0711/002/001 12.5 milligram(s)
Tablet - Captopril 01/07/2020Captor 12.5mg Tablets Rowex Ltd
PA0711/002/001 12.5 milligram(s) Tablet - Captopril
01/07/2020Captor 50mg Tablets Rowex Ltd PA0711/002/003 50
milligram(s) Tablet - Captopril 01/07/2020Captor 50mg Tablets Rowex
Ltd PA0711/002/003 50 milligram(s) Tablet - Captopril
01/07/2020Captor-HCT 25 mg/12.5 mg Tablets
Rowex Ltd PA0711/025/001 25/12.5 mg milligram(s) Tablet -
Captopril- Hydrochlorothiazide
01/07/2020
Captor-HCT 25 mg/12.5 mg Tablets
Rowex Ltd PA0711/025/001 25/12.5 mg milligram(s) Tablet -
Captopril- Hydrochlorothiazide
01/07/2020
Captor-HCT 50mg/25mg Tablets
Rowex Ltd PA0711/025/003 50/25mg milligram(s) Tablet -
Captopril- Hydrochlorothiazide
01/07/2020
Captor-HCT 50mg/25mg Tablets
Rowex Ltd PA0711/025/003 50/25mg milligram(s) Tablet -
Captopril- Hydrochlorothiazide
01/07/2020
Isotrexin 20 mg/g + 0.5 mg/g Gel
GlaxoSmithKline (Ireland) Limited
PA1077/123/001 20+0.5 milligram(s)/gra Gel - Isotretinoin-
Erythromycin
01/07/2020
Dutasteride 0.5 mg soft capsules
Cipla Europe NV PA1963/005/001 0.5 milligram(s) Capsule, soft -
Dutasteride (dmf) 30/06/2020
Dutasteride 0.5 mg soft capsules
Cipla Europe NV PA1963/005/001 0.5 milligram(s) Capsule, soft -
Dutasteride (dmf) 30/06/2020
Stugeron 25 mg Tablets Johnson & Johnson (Ireland)
Limited
PA0330/044/002 25 milligram(s) Tablet - Cinnarizine
30/06/2020
Stugeron 25 mg Tablets Johnson & Johnson (Ireland)
Limited
PA0330/044/002 25 milligram(s) Tablet - Cinnarizine
30/06/2020
Tyrozets Lozenges Johnson & Johnson (Ireland) Limited
PA0330/043/001 1/5 milligram(s) Lozenge - Benzocaine-
Tyrothricin
30/06/2020
Tyrozets Lozenges Johnson & Johnson (Ireland) Limited
PA0330/043/001 1/5 milligram(s) Lozenge - Benzocaine-
Tyrothricin
30/06/2020
Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3
mg film-coated tablets
Laboratorios Leon Farma, S.A.
PA1474/006/001 0.02/3 milligram(s) Film-coated tablet -
Drospirenone- Ethinylestradiol
29/06/2020
Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3
mg film-coated tablets
Laboratorios Leon Farma, S.A.
PA1474/006/001 0.02/3 milligram(s) Film-coated tablet -
Drospirenone- Ethinylestradiol
29/06/2020
Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.03 mg/3
mg film-coated tablets
Laboratorios Leon Farma, S.A.
PA1474/006/002 0.03/3 milligram(s) Film-coated tablet -
Ethinylestradiol- Drospirenone
29/06/2020
Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.03 mg/3
mg film-coated tablets
Laboratorios Leon Farma, S.A.
PA1474/006/002 0.03/3 milligram(s) Film-coated tablet -
Ethinylestradiol- Drospirenone
29/06/2020
Caspofungin 50 mg powder for concentrate for solution for
infusion
Ethypharm PA0549/022/001 50.00 milligram(s) Powder for
concentrate for solution for infusion
- Caspofungin 25/06/2020
Caspofungin 50 mg powder for concentrate for solution for
infusion
Ethypharm PA0549/022/001 50.00 milligram(s) Powder for
concentrate for solution for infusion
- Caspofungin 25/06/2020
Caspofungin 70 mg powder for concentrate for solution for
infusion
Ethypharm PA0549/022/002 70.00 milligram(s) Powder for
concentrate for solution for infusion
- Caspofungin 25/06/2020
Caspofungin 70 mg powder for concentrate for solution for
infusion
Ethypharm PA0549/022/002 70.00 milligram(s) Powder for
concentrate for solution for infusion
- Caspofungin 25/06/2020
Picato Leo Laboratories Limited EU/1/12/796/001 150 Micrograms/g
Gel - Ingenol mebutate 25/06/2020
Picato Leo Laboratories Limited EU/1/12/796/001 150 Micrograms/g
Gel - Ingenol mebutate 25/06/2020
Accolate 20 mg film-coated tablets
AstraZeneca UK Limited PA0970/001/001 20 milligram(s) Tablet -
Zafirlukast 23/06/2020
Human Medicines Withdrawn Products Page 14 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateAccolate 20 mg film-coated
tablets
AstraZeneca UK Limited PA0970/001/001 20 milligram(s) Tablet -
Zafirlukast 23/06/2020
Forane 99.9% w/w, Inhalation Vapour, Liquid
AbbVie Limited PA1824/001/001 99.9 percent weight/weight
Inhalation Gas - Isoflurane 23/06/2020
Forane 99.9% w/w, Inhalation Vapour, Liquid
AbbVie Limited PA1824/001/001 99.9 percent weight/weight
Inhalation Gas - Isoflurane 23/06/2020
Vascace 0.5 mg Film-coated Tablets
Roche Products Limited PA0050/083/001 0.5 milligram(s)
Film-coated tablet - Cilazapril 22/06/2020
Vascace 0.5 mg Film-coated Tablets
Roche Products Limited PA0050/083/001 0.5 milligram(s)
Film-coated tablet - Cilazapril 22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/001 15 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/001 15 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/002 15 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/002 15 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/003 20 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/003 20 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/004 20 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/004 20 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/005 30 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/005 30 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/006 30 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/006 30 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/007 40 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/007 40 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/008 40 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/008 40 milligram(s) Capsule - Stavudine
22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/009 1 milligram(s)/millilitre Powder for oral
solution - Stavudine 22/06/2020
Zerit Bristol Myers Squibb Pharma EEIG
EU/1/96/009/009 1 milligram(s)/millilitre Powder for oral
solution - Stavudine 22/06/2020
Anastrozole 1 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/011/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 18/06/2020
Anastrozole 1 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/011/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 18/06/2020
Lotriderm Merck Sharp & Dohme Ireland (Human Health)
Limited
PA1286/031/001 0.064/1.0 Cream - Clotrimazole- BETAMETHASONE
DIPROPIONATE
18/06/2020
Lotriderm Merck Sharp & Dohme Ireland (Human Health)
Limited
PA1286/031/001 0.064/1.0 Cream - Clotrimazole- BETAMETHASONE
DIPROPIONATE
18/06/2020
Profal 5 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/045/001 5 milligram(s) Film-coated tablet - Finasteride
18/06/2020
Profal 5 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/045/001 5 milligram(s) Film-coated tablet - Finasteride
18/06/2020
Etoricoxib 120 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/004
Interchangeable List Code:IC0108-167-003
120 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Human Medicines Withdrawn Products Page 15 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateEtoricoxib 120 mg film-coated
tablets
Accord Healthcare Ireland Ltd.
PA2315/043/004
Interchangeable List Code:IC0108-167-003
120 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 30 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/001
Interchangeable List Code:IC0108-033-003
30 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 30 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/001
Interchangeable List Code:IC0108-033-003
30 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 60 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/002
Interchangeable List Code:IC0108-127-003
60 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 60 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/002
Interchangeable List Code:IC0108-127-003
60 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 90 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/003
Interchangeable List Code:IC0108-166-003
90 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
Etoricoxib 90 mg film-coated tablets
Accord Healthcare Ireland Ltd.
PA2315/043/003
Interchangeable List Code:IC0108-166-003
90 milligram(s) Film-coated tablet - Etoricoxib 17/06/2020
sdfgsdfgsdfg IMB Test Pharmaceutical Company
PA1836/001/063 Infus/Pdr/Oral Soln - C.perfringens type b &
c toxoid
10/06/2020
TEST product Test MAH PA22671/001/001 . - Ibuprofen
10/06/2020Inderal 10mg Film-coated Tablets
AstraZeneca AB PA1019/010/001 10 milligram(s) Film-coated tablet
- PROPRANOLOL HYDROCHLORIDE
08/06/2020
Inderal 10mg Film-coated Tablets
AstraZeneca AB PA1019/010/001 10 milligram(s) Film-coated tablet
- PROPRANOLOL HYDROCHLORIDE
08/06/2020
Tenoret 50mg/12.5mg Film-coated Tablets
AstraZeneca AB PA1019/021/001 50 mg/12.5 milligram(s)
Film-coated tablet - Atenolol- Chlorthalidone
08/06/2020
Tenoret 50mg/12.5mg Film-coated Tablets
AstraZeneca AB PA1019/021/001 50 mg/12.5 milligram(s)
Film-coated tablet - Atenolol- Chlorthalidone
08/06/2020
Tenoretic 100mg/25mg Film-coated Tablets
AstraZeneca AB PA1019/022/001 100 mg/25 milligram(s) Film-coated
tablet - Atenolol- Chlorthalidone
08/06/2020
Tenoretic 100mg/25mg Film-coated Tablets
AstraZeneca AB PA1019/022/001 100 mg/25 milligram(s) Film-coated
tablet - Atenolol- Chlorthalidone
08/06/2020
Remifentanil 1mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/001 1 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Remifentanil 1mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/001 1 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Remifentanil 2mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/002 2 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Remifentanil 2mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/002 2 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Remifentanil 5mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/003 5 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Remifentanil 5mg powder for concentrate for solution for
injection/infusion
Actavis Group PTC ehf PA1380/112/003 5 milligram(s) Powder for
concentrate for solution for injection/infusion
- Remifentanil 02/06/2020
Human Medicines Withdrawn Products Page 16 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateFetanex 12.5 microgram/hour
Transdermal patch
Rowex Ltd PA0711/137/001 12.5 Microgram per hour Transdermal
patch - Fentanyl 26/05/2020
Fetanex 12.5 microgram/hour Transdermal patch
Rowex Ltd PA0711/137/001 12.5 Microgram per hour Transdermal
patch - Fentanyl 26/05/2020
Fetanex 37.5 microgram/hour Transdermal patch
Rowex Ltd PA0711/137/003 37.5 Microgram per hour Transdermal
patch - Fentanyl 26/05/2020
Fetanex 37.5 microgram/hour Transdermal patch
Rowex Ltd PA0711/137/003 37.5 Microgram per hour Transdermal
patch - Fentanyl 26/05/2020
TOPAMAX 200mg Film-coated Tablets
Lexon (UK) Ltd PPA1097/002/002 200 milligram(s) Film-coated
tablet - Topiramate 14/05/2020
TOPAMAX 200mg Film-coated Tablets
Lexon (UK) Ltd PPA1097/002/002 200 milligram(s) Film-coated
tablet - Topiramate 14/05/2020
TOPAMAX 50mg Film-coated Tablets
Lexon (UK) Ltd PPA1097/002/001 50 milligram(s) Film-coated
tablet - Topiramate 14/05/2020
TOPAMAX 50mg Film-coated Tablets
Lexon (UK) Ltd PPA1097/002/001 50 milligram(s) Film-coated
tablet - Topiramate 14/05/2020
Pipexus 0.26 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/001 0.26 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 0.26 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/001 0.26 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 0.52 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/002 0.52 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 0.52 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/002 0.52 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 1.05 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/003 1.05 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 1.05 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/003 1.05 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 1.57 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/004 1.57 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 1.57 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/004 1.57 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 2.1 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/005 2.1 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 2.1 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/005 2.1 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 2.62 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/006 2.62 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 2.62 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/006 2.62 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 3.15 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/007 3.15 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Pipexus 3.15 mg prolonged-release tablets
Macarthys Laboratories Limited
PA0274/003/007 3.15 milligram(s) Prolonged-release tablet -
Pramipexole dihydrochloride monohydrate
12/05/2020
Anastrozole 1 mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/027/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 11/05/2020
Anastrozole 1 mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/027/001
Interchangeable List Code:IC0011-039-003
1 milligram(s) Film-coated tablet - Anastrozole 11/05/2020
Bicalutamide 150 mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/030/002 150 milligram(s) Film-coated tablet -
Bicalutamide 11/05/2020
Bicalutamide 150 mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/030/002 150 milligram(s) Film-coated tablet -
Bicalutamide 11/05/2020
Human Medicines Withdrawn Products Page 17 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateBicalutamide 50mg Film-coated
tablets
Fresenius Kabi Deutschland GmbH
PA2059/030/001 50 milligram(s) Film-coated tablet - Bicalutamide
11/05/2020
Bicalutamide 50mg Film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/030/001 50 milligram(s) Film-coated tablet - Bicalutamide
11/05/2020
Letrozole 2.5mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/047/001 2.5 milligram(s) Film-coated tablet - Letrozole
11/05/2020
Letrozole 2.5mg film-coated tablets
Fresenius Kabi Deutschland GmbH
PA2059/047/001 2.5 milligram(s) Film-coated tablet - Letrozole
11/05/2020
Zalmoxis MolMed EU/1/16/1121/001 20 Milligram Suspension for
Infusion - Allogeneic t cells mm-tk ds
07/05/2020
Panadol 500 mg Film Coated Tablets
Lexon (UK) Ltd PPA1097/016/001 500 milligram(s) Film-coated
tablet - PARACETAMOL 04/05/2020
Panadol 500 mg Film Coated Tablets
Lexon (UK) Ltd PPA1097/016/001 500 milligram(s) Film-coated
tablet - PARACETAMOL 04/05/2020
Ciprofloxacin 2mg/ml, Solution for Infusion
Baxter Holding B.V. PA2299/034/001 2 milligram(s)/millilitre
Solution for infusion - Ciprofloxacin lactate 01/05/2020
Ciprofloxacin 2mg/ml, Solution for Infusion
Baxter Holding B.V. PA2299/034/001 2 milligram(s)/millilitre
Solution for infusion - Ciprofloxacin lactate 01/05/2020
Prasugrel Rowex 10 mg Film-coated tablets
Rowex Ltd PA0711/282/002 10 milligram(s) Film-coated tablet -
Prasugrel 01/05/2020
Prasugrel Rowex 10 mg Film-coated tablets
Rowex Ltd PA0711/282/002 10 milligram(s) Film-coated tablet -
Prasugrel 01/05/2020
Prasugrel Rowex 5 mg Film-coated tablets
Rowex Ltd PA0711/282/001 5 milligram(s) Film-coated tablet -
PRASUGREL BESILATE
01/05/2020
Prasugrel Rowex 5 mg Film-coated tablets
Rowex Ltd PA0711/282/001 5 milligram(s) Film-coated tablet -
PRASUGREL BESILATE
01/05/2020
DDAVP/Desmopressin 0.1mg Tablets
Ferring Ireland Ltd PA1009/001/003 0.1 milligram(s) Tablet -
DESMOPRESSIN ACETATE
30/04/2020
DDAVP/Desmopressin 0.1mg Tablets
Ferring Ireland Ltd PA1009/001/003 0.1 milligram(s) Tablet -
DESMOPRESSIN ACETATE
30/04/2020
Desmotabs 0.2mg Tablets
Ferring Ireland Ltd PA1009/007/001 0.2 milligram(s) Tablet -
DESMOPRESSIN ACETATE
30/04/2020
Desmotabs 0.2mg Tablets
Ferring Ireland Ltd PA1009/007/001 0.2 milligram(s) Tablet -
DESMOPRESSIN ACETATE
30/04/2020
Octostim 1.5 mg/ml Nasal Spray
Ferring Ireland Ltd PA1009/014/002 1.5 milligram(s)/millilitre
Nasal spray, solution - DESMOPRESSIN ACETATE
30/04/2020
Octostim 1.5 mg/ml Nasal Spray
Ferring Ireland Ltd PA1009/014/002 1.5 milligram(s)/millilitre
Nasal spray, solution - DESMOPRESSIN ACETATE
30/04/2020
Octostim 15 micrograms/ml Solution for injection
Ferring Ireland Ltd PA1009/014/001 15 microgram(s)/millilitre
Solution for injection - DESMOPRESSIN ACETATE
30/04/2020
Octostim 15 micrograms/ml Solution for injection
Ferring Ireland Ltd PA1009/014/001 15 microgram(s)/millilitre
Solution for injection - DESMOPRESSIN ACETATE
30/04/2020
Cystrin 3mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/143/001 3 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Cystrin 3mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/143/001 3 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Cystrin 5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/143/002 5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Cystrin 5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/143/002 5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Ditropan 2.5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/146/002 2.5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Ditropan 2.5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/146/002 2.5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Ditropan 5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/146/003 5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Ditropan 5mg Tablets Sanofi-Aventis Ireland Limited T/A
SANOFI
PA0540/146/003 5 milligram(s) Tablet - OXYBUTYNIN
HYDROCHLORIDE
24/04/2020
Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops
Solution
Accord Healthcare Ireland Ltd.
PA2315/024/001
Interchangeable List Code:IC0100-153-045
50 mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution - Latanoprost- Timolol
24/04/2020
Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops
Solution
Accord Healthcare Ireland Ltd.
PA2315/024/001
Interchangeable List Code:IC0100-153-045
50 mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution - Latanoprost- Timolol
24/04/2020
Sotacor 80 mg Tablets Bristol-Myers Squibb Pharmaceuticals
uc
PA2255/003/001 80 milligram(s) Tablet - SOTALOL
HYDROCHLORIDE
24/04/2020
Sotacor 80 mg Tablets Bristol-Myers Squibb Pharmaceuticals
uc
PA2255/003/001 80 milligram(s) Tablet - SOTALOL
HYDROCHLORIDE
24/04/2020
Varuby TESARO Bio Netherlands B.V.
EU/1/17/1180/001 90 milligram(s) Film-coated tablet - Rolapitant
24/04/2020
Human Medicines Withdrawn Products Page 18 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateVaruby TESARO Bio
Netherlands B.V.EU/1/17/1180/001 90 milligram(s) Film-coated
tablet - Rolapitant 24/04/2020
Xatral 2.5mg Film-Coated Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/162/001 2.5 milligram(s) Film-coated tablet - ALFUZOSIN
HYDROCHLORIDE
24/04/2020
Xatral 2.5mg Film-Coated Tablets
Sanofi-Aventis Ireland Limited T/A SANOFI
PA0540/162/001 2.5 milligram(s) Film-coated tablet - ALFUZOSIN
HYDROCHLORIDE
24/04/2020
Dassan 700 mg Medicated Plaster
Grunenthal Pharma Ltd PA2242/002/001 700 milligram(s) Medicated
plaster - Lidocaine 22/04/2020
Dassan 700 mg Medicated Plaster
Grunenthal Pharma Ltd PA2242/002/001 700 milligram(s) Medicated
plaster - Lidocaine 22/04/2020
Lonqtiv 700 mg Medicated Plaster
Grunenthal Pharma Ltd PA2242/011/001 700 milligram(s) Medicated
plaster - Lidocaine 22/04/2020
Lonqtiv 700 mg Medicated Plaster
Grunenthal Pharma Ltd PA2242/011/001 700 milligram(s) Medicated
plaster - Lidocaine 22/04/2020
Topamax 100mg film-coated tablets
IMED Healthcare Ltd. PPA1463/106/002 100 milligram(s)
Film-coated tablet - Topiramate 16/04/2020
Topamax 100mg film-coated tablets
IMED Healthcare Ltd. PPA1463/106/002 100 milligram(s)
Film-coated tablet - Topiramate 16/04/2020
Vesitirim 10mg Film-coated Tablets
IMED Healthcare Ltd. PPA1463/046/002 10 milligram(s) Film-coated
tablet - Solifenacin succinate 16/04/2020
Vesitirim 10mg Film-coated Tablets
IMED Healthcare Ltd. PPA1463/046/002 10 milligram(s) Film-coated
tablet - Solifenacin succinate 16/04/2020
Vesitirim 5 mg Film-coated Tablets
IMED Healthcare Ltd. PPA1463/046/001 5 milligram(s) Film-coated
tablet - Solifenacin succinate 16/04/2020
Vesitirim 5 mg Film-coated Tablets
IMED Healthcare Ltd. PPA1463/046/001 5 milligram(s) Film-coated
tablet - Solifenacin succinate 16/04/2020
Zovirax 200mg Dispersible Tablets
IMED Healthcare Ltd. PPA1463/132/002 200 milligram(s)
Dispersible tablet - ACICLOVIR 16/04/2020
Zovirax 200mg Dispersible Tablets
IMED Healthcare Ltd. PPA1463/132/002 200 milligram(s)
Dispersible tablet - ACICLOVIR 16/04/2020
OSSEOR Les Laboratoires Servier EU/1/04/287/001 2 g percent
volume/volume
Granules for oral suspension
- Strontium ranelate 14/04/2020
OSSEOR Les Laboratoires Servier EU/1/04/287/001 2 g percent
volume/volume
Granules for oral suspension
- Strontium ranelate 14/04/2020
PROTELOS Les Laboratoires Servier EU/1/04/288/1-6 2g percent
volume/volume
Granules for oral suspension
- Strontium ranelate 14/04/2020
PROTELOS Les Laboratoires Servier EU/1/04/288/1-6 2g percent
volume/volume
Granules for oral suspension
- Strontium ranelate 14/04/2020
Seroxat 20 mg film-coated tablets
Lexon (UK) Ltd PPA1097/040/001
Interchangeable List Code:IC0076-003-003
20 milligram(s) Film-coated tablet - Paroxetine hydrochloride
hemihydrate
14/04/2020
Seroxat 20 mg film-coated tablets
Lexon (UK) Ltd PPA1097/040/001
Interchangeable List Code:IC0076-003-003
20 milligram(s) Film-coated tablet - Paroxetine hydrochloride
hemihydrate
14/04/2020
Seroxat 30 mg film-coated tablets
LTT Pharma Limited PPA1562/030/004
Interchangeable List Code:IC0076-033-003
30 milligram(s) Film-coated tablet - Paroxetine hydrochloride
hemihydrate
14/04/2020
Seroxat 30 mg film-coated tablets
LTT Pharma Limited PPA1562/030/004
Interchangeable List Code:IC0076-033-003
30 milligram(s) Film-coated tablet - Paroxetine hydrochloride
hemihydrate
14/04/2020
Ambrisentan betapharm 10 mg film-coated tablets.
Betapharm Arzneimittel GmbH
PA22717/001/002 10 milligram(s) Film-coated tablet - Ambrisentan
07/04/2020
Ambrisentan betapharm 10 mg film-coated tablets.
Betapharm Arzneimittel GmbH
PA22717/001/002 10 milligram(s) Film-coated tablet - Ambrisentan
07/04/2020
Ambrisentan betapharm 5 mg film-coated tablets.
Betapharm Arzneimittel GmbH
PA22717/001/001 5 milligram(s) Film-coated tablet - Ambrisentan
07/04/2020
Ambrisentan betapharm 5 mg film-coated tablets.
Betapharm Arzneimittel GmbH
PA22717/001/001 5 milligram(s) Film-coated tablet - Ambrisentan
07/04/2020
Ibuprofen Chanelle Medical 200 mg capsules, soft
Chanelle Medical PA0688/053/001 200 milligram(s) Capsule, soft -
Ibuprofen lysine 07/04/2020
Ibuprofen Chanelle Medical 200 mg capsules, soft
Chanelle Medical PA0688/053/001 200 milligram(s) Capsule, soft -
Ibuprofen lysine 07/04/2020
Human Medicines Withdrawn Products Page 19 of 704
-
Trade Name Licence Holder Licence Number Strength Dosage Form
Active Ingredients Withdrawal DateIbuprofen Chanelle Medical 400 mg
capsules, soft
Chanelle Medical PA0688/053/002 400 milligram(s) Capsule, soft -
Ibuprofen lysine 07/04/2020
Ibuprofen Chanelle Medical 400 mg capsules, soft
Chanelle Medical PA0688/053/002 400 milligram(s) Capsule, soft -
Ibuprofen lysine 07/04/2020
Lemsip Cold & Flu 500 mg tablets
Reckitt Benckiser Ireland Ltd
PA0979/051/001 500 milligram(s) Tablet - Paracetamol
07/04/2020
Lemsip Cold & Flu 500 mg tablets
Reckitt Benckiser Ireland Ltd
PA0979/051/001 500 milligram(s) Tablet - Paracetamol
07/04/2020
Lemsip Decongestant & Flu Lemon Tablets Paracetamol 500 mg
Phenylephrine Hydrochloride 6.1 mg
Reckitt Benckiser Ireland Ltd
PA0979/050/001 500 mg/6.1 milligram(s) Tablet - Paracetamol-
Phenylephrine hydrochloride
07/04/2020
Lemsip Decongestant & Flu Lemon Tablets Paracetamol 500 mg
Phenylephrine Hydrochloride 6.1 mg
Reckitt Benckiser Ireland Ltd
PA0979/050/001 500 mg/6.1 milligram(s) Tablet - Paracetamol-
Phenylephrine hydrochloride
07/04/2020
Lemsip Decongestant and Flu Blackcurrant tablets Paracetamol
500mg Phenylephrine hydrochloride 6.1mg
Reckitt Benckiser Ireland Ltd
PA0979/050/002 500 mg / 6.1 milligram(s) Tablet - Paracetamol-
Phenylephrine hydrochloride
07/04/2020
Lemsip Decongestant and Flu Blackcurrant tablets Paracetamol
500mg Phenylephrine hydrochloride 6.1mg
Reckitt Benckiser Ireland Ltd
PA0979/050/002 500 mg / 6.1 milligram(s) Tablet - Paracetamol-
Phenylephrine hydrochloride
07/04/2020
Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml
suspension for injection, 1 ml
Bristol-Myers Squibb Pharmaceuticals uc
PA0002/018/002 10 milligram(s)/millilitre Suspension for
injection - Triamcinolone acetonide
01/04/2020
Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml
suspension for injection, 1 ml
Bristol-Myers Squibb Pharmaceuticals uc
PA0002/018/002 10 milligram(s)/millilitre Suspension for
injection - Triamcinolone acetonide
01/04/2020
Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension
Merck Sharp & Dohme Ireland (Human Health) Limited
PA1286/004/004 2.5 milligram(s)/millilitre Powder for oral
suspension
- Losartan potassium 01/04/2020
Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension
Merck Sharp & Dohme Ireland (Human Health) Limited
PA1286/004/004 2.5 milligram(s)/millilitre Powder for oral
suspension
- Losartan potassium 01/04/2020
Delmosart PR 18 mg prolonged-release tablets
Accord Healthcare Ireland Ltd.
PA2315/147/001 18 milligram(s) Prolonged-release tablet -
Methylphenidate hydrochloride
01/04/2020
Delmosart PR 18 mg prolonged-release tablets
Accord Healthcare Ireland Ltd.
PA2315/147/001 18 m